Comparison of 3 Techniques for Recreation of Anterior Cruciate Ligament Anatomic Footprint

NCT ID: NCT02795247

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-26

Study Completion Date

2023-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the tomographic results of patients who underwent single-bundle anterior cruciate ligament reconstruction at the investigator's institution using the transtibial, accessory medial portal technique and the modified transtibial technique to determine which technique best recreates the anterior cruciate ligament anatomic footprint.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Reconstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transtibial Technique

Reconstruction of the ACL using the transtibial technique.

Group Type ACTIVE_COMPARATOR

Anterior Cruciate Ligament Reconstruction

Intervention Type PROCEDURE

Hybrid Transtibial Technique

Reconstruction of the ACL using the hybrid transtibial technique

Group Type ACTIVE_COMPARATOR

Anterior Cruciate Ligament Reconstruction

Intervention Type PROCEDURE

Accessory Anteromedial Portal Technique

Reconstruction of the ACL using the accessory anteromedial portal technique

Group Type ACTIVE_COMPARATOR

Anterior Cruciate Ligament Reconstruction

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anterior Cruciate Ligament Reconstruction

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ACL Reconstruction

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients presenting for single bundle ACL reconstruction, with or without associated partial meniscectomy or meniscal repair.
* Skeletally mature patients
* Patients who are able and willing to receive post-operative CT imaging of the affected knee

Exclusion Criteria

* Previous ACL reconstruction in the studied knee
* Previous ACL injury or reconstruction in the contralateral kneeConcomitant non-ACL ligament reconstruction or osteotomy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dana P Piasecki, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina Research Institute, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

OrthoCarolina Sports Center

Charlotte, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Robin BN, Jani SS, Marvil SC, Reid JB, Schillhammer CK, Lubowitz JH. Advantages and Disadvantages of Transtibial, Anteromedial Portal, and Outside-In Femoral Tunnel Drilling in Single-Bundle Anterior Cruciate Ligament Reconstruction: A Systematic Review. Arthroscopy. 2015 Jul;31(7):1412-7. doi: 10.1016/j.arthro.2015.01.018. Epub 2015 Mar 5.

Reference Type BACKGROUND
PMID: 25749530 (View on PubMed)

Youm YS, Cho SD, Eo J, Lee KJ, Jung KH, Cha JR. 3D CT analysis of femoral and tibial tunnel positions after modified transtibial single bundle ACL reconstruction with varus and internal rotation of the tibia. Knee. 2013 Aug;20(4):272-6. doi: 10.1016/j.knee.2012.10.024. Epub 2012 Nov 26.

Reference Type BACKGROUND
PMID: 23195998 (View on PubMed)

Lee MC, Seong SC, Lee S, Chang CB, Park YK, Jo H, Kim CH. Vertical femoral tunnel placement results in rotational knee laxity after anterior cruciate ligament reconstruction. Arthroscopy. 2007 Jul;23(7):771-8. doi: 10.1016/j.arthro.2007.04.016.

Reference Type BACKGROUND
PMID: 17637414 (View on PubMed)

Alentorn-Geli E, Lajara F, Samitier G, Cugat R. The transtibial versus the anteromedial portal technique in the arthroscopic bone-patellar tendon-bone anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2010 Aug;18(8):1013-37. doi: 10.1007/s00167-009-0964-0. Epub 2009 Nov 10.

Reference Type BACKGROUND
PMID: 19902178 (View on PubMed)

Takeda Y, Iwame T, Takasago T, Kondo K, Goto T, Fujii K, Naruse A. Comparison of tunnel orientation between transtibial and anteromedial portal techniques for anatomic double-bundle anterior cruciate ligament reconstruction using 3-dimensional computed tomography. Arthroscopy. 2013 Feb;29(2):195-204. doi: 10.1016/j.arthro.2012.08.020. Epub 2012 Dec 24.

Reference Type BACKGROUND
PMID: 23270788 (View on PubMed)

de Abreu-e-Silva GM, de Oliveira MH, Maranhao GS, Deligne Lde M, Pfeilsticker RM, Novais EN, Nunes TA, de Andrade MA. Three-dimensional computed tomography evaluation of anterior cruciate ligament footprint for anatomic single-bundle reconstruction. Knee Surg Sports Traumatol Arthrosc. 2015 Mar;23(3):770-6. doi: 10.1007/s00167-013-2703-9. Epub 2013 Oct 22.

Reference Type BACKGROUND
PMID: 24146049 (View on PubMed)

Larson AI, Bullock DP, Pevny T. Comparison of 4 femoral tunnel drilling techniques in anterior cruciate ligament reconstruction. Arthroscopy. 2012 Jul;28(7):972-9. doi: 10.1016/j.arthro.2011.12.015. Epub 2012 Mar 10.

Reference Type BACKGROUND
PMID: 22409948 (View on PubMed)

Osaki K, Okazaki K, Matsubara H, Kuwashima U, Murakami K, Iwamoto Y. Asymmetry in Femoral Tunnel Socket Length During Anterior Cruciate Ligament Reconstruction With Transportal, Outside-In, and Modified Transtibial Techniques. Arthroscopy. 2015 Dec;31(12):2365-70. doi: 10.1016/j.arthro.2015.06.026. Epub 2015 Aug 24.

Reference Type BACKGROUND
PMID: 26315055 (View on PubMed)

Bernard M, Hertel P, Hornung H, Cierpinski T. Femoral insertion of the ACL. Radiographic quadrant method. Am J Knee Surg. 1997 Winter;10(1):14-21; discussion 21-2.

Reference Type BACKGROUND
PMID: 9051173 (View on PubMed)

Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654.

Reference Type BACKGROUND
PMID: 20516317 (View on PubMed)

Sohn OJ, Lee DC, Park KH, Ahn HS. Comparison of the Modified Transtibial Technique, Anteromedial Portal Technique and Outside-in Technique in ACL Reconstruction. Knee Surg Relat Res. 2014 Dec;26(4):241-8. doi: 10.5792/ksrr.2014.26.4.241. Epub 2014 Dec 2.

Reference Type BACKGROUND
PMID: 25505707 (View on PubMed)

Trofa DP, Saltzman BM, Corpus KT, Connor PM, Fleischli JE, Piasecki DP. A Hybrid Transtibial Technique Combines the Advantages of Anteromedial Portal and Transtibial Approaches: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Nov;48(13):3200-3207. doi: 10.1177/0363546520956645. Epub 2020 Oct 5.

Reference Type DERIVED
PMID: 33017169 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SPORT037

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tourniquet Use in Anterior Cruciate Ligament Repair
NCT05931627 ENROLLING_BY_INVITATION NA